Cardiac Assist, Inc 2023-09-06 Health serious FDA
Health · FDA · Recall #FDA-Z-2465-2023
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray… Recall
Issued September 6, 2023 · Cardiac Assist, Inc
In September 2023, Cardiac Assist, Inc recalled the LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,
What you should do
- 1 Stop using LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Cardiac Assist, Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Cardiac Assist, Inc
- Category
- Health
- Recall date
- September 6, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of IL, FL.
- Recall number
- FDA-Z-2465-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Cardiac Assist, Inc has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.